Effect of Fenugreek and Cumin Powder on Overweight and Obese People

Sponsor
University of Veterinary and Animal Sciences, Lahore - Pakistan (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05966935
Collaborator
(none)
60
2
3.2

Study Details

Study Description

Brief Summary

The objective of this study is to investigate the effect of fenugreek and cumin powder on the anthropometric indices of overweight and obese adults aged 18-30 years. This study design intends to answer following question:

Will fenugreek and cumin powder mixture result in change of anthropometric measurements (BMI, Waist-Hip Ratio, Fat Mass)

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Fenugreek Cumin Powder
N/A

Detailed Description

Obesity is a chronic disorder of carbohydrate and lipid metabolism and is characterized by an increased fat deposition in adipose tissue and other internal organs .

Obesity leads to the development of insulin resistance, type-2 diabetes, coronary heart disease, cancer, respiratory disease, and osteoarthritis. The World Obesity Atlas 2022 predicts that one billion people globally, including 1 in 5 women and 1 in 7 men, will be living with obesity by 2030.

Pakistan ranks tenth out of 188 countries, with 50% of population overweight or obese Several studies have investigated the effect of fenugreek and cumin supplementation on anthropometric measures but the findings have been inconsistent. Only few studies directly focused on powder supplementation. The study aims to investigate the effect of fenugreek and cumin powder supplementation on body measurements for weight loss. This will help in developing a rather inexpensive, herbal mixture for weight loss.

Galactomannan present in fenugreek capture and excrete sugars from body before it moves in the blood, this causes the loss of weight The percent gain in body weight was significantly low in groups supplemented with fenugreek Cumin improves anthropometric indices in overweight. Cumin powder reduced weight, BMI, waist circumference, fat mass and percentage significantly.

This study consists of following phases Phase 1: Fenugreek and cumin powder preparation Phase 2: 30 Participants will be recruited after filling the consent form and screened through a questionnaire throughout the university. Individuals with BMI >23kg/m2, WHR >0.8 will be recruited in the study after fulfilling the criterion (patients of thyroid, PCOS, HTN will be excluded). Participants not following any fitness regime or specific diet will be recruited further. Baseline body measurements will be taken by inbody analyzer. They will be given powder packed in packets to be used for 8 weeks twice a day before breakfast and dinner. Experimental Design : Overweight and obese adults will be assigned to two groups ( Intervention group and control). Participants will be requested to record the following information daily: Consumption of FCP( fenugreek cumin powder) and any side effects if experienced after consumption.

The control group will not receive powder or any other intervention. Phase 3: Measurements will be taken after intervention

Statistical Analysis:

Microsoft excel will be used for data coding. Descriptive analysis will be done by using SPSS version 23( SPSS for windows version 23; SPSS Inc., Chicago, IL, USA).

Independent sample t-test and Pearson chi-square will be performed to compare the treatment and control groups. P value < 0.05 will be considered significant for all analysis.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be divided into two groups. One group will receive the Fenugreek Cumin Powder. The other group will not receive the powderParticipants will be divided into two groups. One group will receive the Fenugreek Cumin Powder. The other group will not receive the powder
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Fenugreek and Cumin Powder on Anthropometric Indices of Overweight and Obese Adults
Anticipated Study Start Date :
Aug 15, 2023
Anticipated Primary Completion Date :
Oct 20, 2023
Anticipated Study Completion Date :
Nov 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: fenugreek cumin powder

Experimental :Fenugreek and Cumin Powder Overweight and Obese adults in this group will receive fenugreek cumin powder daily twicw a day before morning and evening meals for 8 weeks

Combination Product: Fenugreek Cumin Powder
Fenugreek and Cumin seeds will be procured from the market. They will be cleaned of debris, winnowed, and grinded to fine powder passed through a mesh size of 30 for metal cleaning. 5g of fenugreek powder and 5g of cumin powder will be packed in packets. Participants in the intervention group will be instructed to consume the powder before breakfast and dinner with a glass of water.

No Intervention: no treatment

Control group In this group, the overweight and obese participants will not receive fenugreek and cumin powder or any intervention for 8 weeks

Outcome Measures

Primary Outcome Measures

  1. weight change in kilograms [change from baseline weight after 2 months]

    Electronic weighing scale will be used to assess weight change in both groups

  2. Change in Body fat mass in kilograms and percentages [change from baseline readings after 2 months]

    body fat mass and percentage will be assessed through inbody analyzer 270

  3. Change in BMI in kg/m^2 [change from baseline reading after 2 months]

    the BMI will be calculated using weight(kg) and height(m^2)

  4. Change in Waist- Hip Ratio [change from baseline reading after 2 months]

    the WHR will be calculated using inbody analyzer 270

Secondary Outcome Measures

  1. Change in Basal metabolic Rate( BMR) [Change from baseline after 2 months]

    The BMR will be calculated using Inbody analyzer 270

  2. change in Protein mass of body (grams) [change from baseline reading after 2 months]

    this protein mass will be assessed through Inbody analyzer 270

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • overweight and obese( BMI>23 kg/m^2)
Exclusion Criteria:
  • pregnant women

  • Thyroid

  • PCOS

  • HTN

  • fitness regime

  • specific diet

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Veterinary and Animal Sciences, Lahore - Pakistan

Investigators

  • Principal Investigator: Sanaullah Iqbal, PhD, University of Veterinary and Animal Sciences Lahore, Punjab

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sanaullah Iqbal, Professor, University of Veterinary and Animal Sciences, Lahore - Pakistan
ClinicalTrials.gov Identifier:
NCT05966935
Other Study ID Numbers:
  • Fenugreek and cumin powder
First Posted:
Aug 1, 2023
Last Update Posted:
Aug 1, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sanaullah Iqbal, Professor, University of Veterinary and Animal Sciences, Lahore - Pakistan
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 1, 2023